Comparison of Immunogenicity and Safety of Inactivated and Live-attenuated Hepatitis A Virus Vaccine Among Thai Healthy Children and Adolescents: A Randomized, Active-controlled, Open-label, Non-inferiority Trial

PED-2566-0634

Hepatitis A virus (HAV) vaccine is an effective strategy to prevent natural HAV infection. In Thailand, there are 2 types of HAV vaccine available, including inactivated HAV vaccine and live-attenuated HAV vaccine. This study aims to compare the immunogenicity and safety of inactivated and lived-attenuated HAV vaccine among Thai healthy children and adolescents age 18 months to 18 years.

2024-04-01

2025-03-01

2025-06-01

Not yet recruiting

Early phase I

120

Inclusion Criteria: * Age between 18 months and 18 years * Has healthy status * Has no history of hepatitis A infection or previous hepatitis A disease * Has never received hepatitis A vaccine (from vaccine booklet or parental history) * Participants and/or caregivers gives written inform consent/assent form Exclusion Criteria: * Has acute illness within 4 weeks before enrollment * Has fever with jaundice within 4 weeks before enrollment * Has underlying disease of thrombocytopenia, coagulopathy, hemophilia A or B, neurologic disease, immunocompromised condition, chronic liver disease, chronic hepatitis B or C infection * Has received immunosuppressive agents or immunomodulatory agents, corticosteroid \>2 mg/kg/day or 20 mg/day within 6 months before enrollment * Has received blood or blood component, or intravenous immunoglobulin within 6 months before enrollment * Has received any lived-attenuated vaccine within 30 days before enrollment * Has history of severe allergy to vaccine or vaccine component, including aluminum hydroxide, 2-phenoxyethanol, neomycin, formaldehyde, gentamicin sulfate, or has history of anaphylaxis or severe allergic reactions following vaccination * Women planning for pregnancy, pregnant women or lactating women * Women in childbearing age who cannot use contraceptive methods during study participation * Is concurrently involved in other clinical trials in which receiving an investigational vaccine or study drug as part of study participation * Have any condition that, in the opinion of the site investigator, would compromise the subject's ability to participate in the study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

2024-03-08